{
  "meta": {
    "disclaimer": "Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. We may limit or otherwise restrict your access to the API in line with our Terms of Service.",
    "terms": "https://open.fda.gov/terms/",
    "license": "https://open.fda.gov/license/",
    "last_updated": "2026-04-01",
    "results": {
      "skip": 0,
      "limit": 1,
      "total": 1
    }
  },
  "results": [
    {
      "status": "Terminated",
      "city": "North Billerica",
      "state": "MA",
      "country": "United States",
      "classification": "Class II",
      "openfda": {},
      "product_type": "Devices",
      "event_id": "84828",
      "recalling_firm": "Breas Medical, Inc.",
      "address_1": "16 Esquire Rd",
      "address_2": "N/A",
      "postal_code": "01862-2527",
      "voluntary_mandated": "Voluntary: Firm initiated",
      "initial_firm_notification": "Letter",
      "distribution_pattern": "Worldwide distribution - US Nationwide distribution in the states of AR, CA, FL, GA, IA, IL, KS, MA, MI, MO, NJ, NY, OH, PR, SC, TX, VA, WI and countries distribution worldwide.",
      "recall_number": "Z-1352-2020",
      "product_description": "Protective Cover Vivo 55/65 (Used for Vivo 50/65), Part No. 006344. It is an accessory (i.e. protective cover) for the Vivo 50 and Vivo 65 ventilators - Product Usage: The protective cover is intended for additional protection of the Vivo 50, Vivo 55, Vivo 60 and Vivo 65 ventilators during transportation, and in hospital, institutional, and home care environments. It can be used while the Vivo ventilators is operating, for example mounted on a wheelchair, in a personal vehicle, or carried by hand. The device is not to be used with the protective cover while positioned in a warm place, such as in direct sunlight or close to a radiator. The protective cover includes the following features: transparent window for accessing front panel and buttons; port for patient circuit, cables, O2 inlet, and standby button; cooling air inlet; patient air inlet; straps for safe mounting; and cooling air outlet.",
      "product_quantity": "629",
      "reason_for_recall": "The outlet hole of the exhalation valve control pressure tube on the ventilator may become obstructed by the protective cover.",
      "recall_initiation_date": "20200128",
      "center_classification_date": "20200224",
      "termination_date": "20200915",
      "report_date": "20200304",
      "code_info": "The cover does not have a lot number; these covers were distributed between  01/11/2018 and 12/17/2019"
    }
  ]
}